A Study Comparing Two Treatments: Direct Glue Injection vs. Targeted Ultrasound-Guided Treatment with Glue and Coils to Stop Bleeding from Swollen Stomach Vein

An Open label Randomized controlled trial to assess the efficacy of EUS guided Coiling and Glue injection compared to conventional glue injection (Direct endoscopic injection) in prevention of late rebleed among patients with bleeding gastric varices

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082426

Enrollment

110

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: Endoscopic glue injection: Endoscopic injection of cyanoacrylate glue Control Intervention1: EUS guided coil and glue injection: Endoscopic ultrasound-guided coil embolization combined

Eligibility

Inclusion criteria

Inclusion criteria: 1. Upper GI bleed secondary to bleeding gastric varices 2. Gastric varices amenable to EUS/Endoscopic therapy

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Platelets count less than 50,000 3. International Normalized Rate (INR) more than 2. 4. Patients with Child C cirrhosis 5. Patients in altered sensorium 6. Hepatorenal syndrome 7. Sepsis 8. Multiorgan failure, 9. Previous endoscopic treatment for GVs, 10. Malignancy 11. Portal and splenic vein thrombosis 12. Oesophageal stricture

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of DEI of CYA versus EUS guided coiling and glue for control of late rebleeding in patients with bleeding gastric varicesTimepoint: Follow up at 2 weeks, 4 weeks and 12 weeks after therapy	—

Secondary

Measure	Time frame
Early rebleeding Complications, Duration of hospital stay Cost of therapy Timepoint: Early rebleeding - 2 - 5 days of therapy	—

Countries

India

Contacts

Public ContactSudipta Dhar Chowdhury

Christian Medical College, Vellore

sudiptadharchowdhury@gmail.com9952311988

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026